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It is a single-arm, open-label, multicenter, phase I trial,aiming at exploring the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,observing the preliminary efficacy.
The trial can be divided into two parts: dose escalation part and dose expansion part.
Camrelizumab will be administrated intravenously in a predetermined fixed dose(200mgQ3w）in both parts.
In dose escalation part,Linperlisib will be administrated from 40mgQD,60mgQD to 80 mgQD in sequence with the classic "3+3" design.The purposes of this part are figuring out the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,and observing the PK characteristics of Linperlisib when using combination with Camrelizumab.
When finishing the dose escalation part,one combination dose of Linperlisib with Carelizumab will be selected to be studied on a wider scale of patients with advantage solid tumor in dose expansion part.Purposes of this part are further observing the PK characteristics of Linperlisib when using combination with Camrelizumab,while observing the preliminary efficacy of Linperlisib when using combination with Camrelizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linperlisib +Camrelizumab 200mgQ3w | Experimental | Linperlisib will be administrated orally from 40mgQD, 60mgQD to 80mgQD in sequence during dose excalation part and a selected dose in dose expansion part,for 21 consecutive days as a treatment cycle; Camrelizumab will be administrated intravenously 200mg every 3 weeks in all patients just before the administration of Linperlisib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linperlisib Tablet | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs | dose limited toxicities | At the end of Cycle 1 (each cycle is 21 days) |
| TEAEs | treatment emergent adverse events | from day 1after taking the investigational product till 30 days after withdrew from the study |
| Measure | Description | Time Frame |
|---|---|---|
| Drug exposure | Peak Plasma Concentration (Cmax) | At the end of Cycle 1 (each cycle is 21 days) |
| PK parameters | Area under the plasma concentration versus time curve (AUC).etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Doctor | Contact | 13902282893 | zhangli@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, Doctor | Cancer Hospital affiliated to Sun Yat-sen University | Principal Investigator |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| At the end of Cycle 1 (each cycle is 21 days) |
| Effectiveness evaluation index | ORR、DOR、DCR、TTR、PFS、OS | From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months |